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Comparing Fascia Iliaca Compartment Block and Pericapsular Nerve Group Block for Hip Fracture Pain Control

Primary Purpose

Hip Fractures, Analgesia, Nerve Blocks

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fascia iliaca compartment block
Pericapsular nerve group block
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled for surgical treatment for hip fracture
  • American Society of Anesthesiologists (ASA) physical status I-III

Exclusion Criteria:

  • allergy to local anesthetics
  • pregnancy
  • inability to understand and use the numerical rating scale (NRS 0-10, 0: no pain, 10: worst pain imaginable) after instruction
  • chronic use of opioids
  • coagulopathy
  • neuropathy
  • severe diabetic mellitus

Sites / Locations

  • Mackay Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fascia iliaca compartment block

Pericapsular nerve group block group

Arm Description

Participants will receive fascia iliaca compartment block before spinal anesthesia and operation

Participants will receive pericapsular nerve group block before spinal anesthesia and operation

Outcomes

Primary Outcome Measures

Pain measurement at rest
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest
Pain measurement during internal rotation
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity

Secondary Outcome Measures

Pain measurement at rest
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest
Pain measurement during internal rotation
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity
Pain measurement at rest
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest
Pain measurement during internal rotation
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity
pain measurement during positioning for spinal anesthesia
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during changing position from supine to lateral decubitus with flexion of the healthy hip
pain measurement after operation
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable)
the time spending for performing spinal anesthesia
defined as starting of positioning maneuver to removal of spinal needle
quality of position for spinal anesthesia
characterized as unsatisfied, satisfied, good, and excellent by the anesthesiologists performing the spinal anesthesia
the first time of pain perceived by the patient after operation
the time interval between the end of operation and pain first perceived by the patient
the time of first request for rescue analgesics after operation
the time interval between the end of operation and the first request for rescue analgesics
total consumption of rescue analgesics within 24 hours after the operation
total consumption of rescue analgesics within 24 hours after the operation
the first time of ambulation after operation
the time interval between the end of operation and the first time the patient can ambulate with assistance after operation
the time spending for nerve block
defined as from contact of skin by the ultrasound transducer to removal of the needle

Full Information

First Posted
December 19, 2019
Last Updated
March 15, 2023
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04210700
Brief Title
Comparing Fascia Iliaca Compartment Block and Pericapsular Nerve Group Block for Hip Fracture Pain Control
Official Title
Comparing Fascia Iliaca Compartment Block With Pericapsular Nerve Group Block for Hip Fracture Pain Control Before Operation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
December 4, 2023 (Anticipated)
Study Completion Date
December 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the study is to compare the analgesic effect of fascia iliaca compartment block (FIC) block and pericapsular nerve group (PENG) block in hip fracture pain control. The participants, caregivers, and assessors will be blinded to the type of block the participants receive. Patients aged 20 years or older with hip fracture scheduled for surgical treatment will be assessed for eligibility to participate the study. One hundred eligible patients will be included in the study after informed consents are obtained, and then randomly allocated into either FIC block or PENG block, with 50 patients in each group. Both blocks will performed under ultrasound guidance. The followings will be assessed: the numerical rating pain scale (NRS 0-10, 0: no pain, 10: worst pain imaginable) at before and after nerve block at different time points during rest and passive internal rotation of the fractured lower limb to neutral position from its typical external rotation deformity 30 mins after block (primary outcome). The degree of patient's satisfaction regarding nerve blocks and anesthesiologist's satisfaction regarding patient position during spinal anesthesia will also be assessed. The pain and use of rescue analgesics in the first 24 hours after operation will be recorded.
Detailed Description
The aim of this study is to compare the analgesic effect of fascia iliaca compartment block (FIC) block and pericapsular nerve group (PENG) block in hip fracture pain control before operation. Methods This will be a randomized, assessor and participant-blinded study. After the patients give his /her informed consents, his/her baseline demographic data (gender, age, height, and body weight) and types of hip fracture will be recorded. Participants will be randomly allocated into either FIC block or PENG block by using the website RESEARCH RANDOMIZER (https://www.randomizer.org). One of the two anesthesiologists experienced in performed the FIC and PENG blocks will perform the nerve blocks. Only the anesthesiologist performing the nerve block and his assistant will be aware of which nerve block the participant receives immediately before performing nerve block by opening a sealed envelope. The assessors, in-charge anesthesiologists and nurse anesthetists, operation room personnel, surgeons and study participants will be all blinded to the randomization. On arrival of the operating theater, all participants will be sent to the nerve block area, where continuous electrocardiogram, pulse oximetry, and non-invasive intermittent blood pressure monitoring will be applied and an intravenous line will be established. Before any intervention, pain at rest and during the fractured lower limb being passively internal rotated in extension to neutral position from its usual externally rotated deformity by assessors will assessed using NRS. If the participant cannot tolerate passive internal rotation of his/her fractured limb due to pain, impossibility to perform the test will be recorded as well as the worst NRS score during these attempts. The same assessment will be performed every 10 mins for until 30 mins after completion of the nerve block. Then the patient will be sent to the operation room, where spinal anesthesia will be performed for the surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Analgesia, Nerve Blocks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fascia iliaca compartment block
Arm Type
Active Comparator
Arm Description
Participants will receive fascia iliaca compartment block before spinal anesthesia and operation
Arm Title
Pericapsular nerve group block group
Arm Type
Experimental
Arm Description
Participants will receive pericapsular nerve group block before spinal anesthesia and operation
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca compartment block
Intervention Description
A linear ultrasound transducer is placed in a sagittal plane to identify the anterior superior iliac spine. By sliding the transducer medially, the fascia iliaca and abdominal internal oblique, sartorius, and iliopsoas muscles are identified. After identifying the "bow-tie sign", a 23-gauge needle (7mm, Nipro, Japan) is inserted in plane from caudal to cephalad until the needle tip penetrate the fascia iliaca. After negative aspiration, 0.35% ropivacaine 30mL with 1:400,000 epinephrine will be injected to separate the fascia iliaca and the iliacus muscle.
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group block
Intervention Description
A curvilinear ultrasound transducer is initially place on the anterior inferior iliac spine and then aligned to the iliopubic eminence by rotating around 45 degree. In this view, the iliopubic eminence, iliapsoas muscle and tendon, pectineus muscle, femoral artery and vein will be identified. A 23-gauge needle (7mm, Nipro, Japan) is inserted in plane from lateral to medial until the needle tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. After negative aspiration, 0.35% ropivacaine 20mL with 1:400,000 epinephrine will be injected.
Primary Outcome Measure Information:
Title
Pain measurement at rest
Description
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest
Time Frame
30 minutes after nerve blocks
Title
Pain measurement during internal rotation
Description
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity
Time Frame
30 minutes after nerve blocks
Secondary Outcome Measure Information:
Title
Pain measurement at rest
Description
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest
Time Frame
10 minutes after nerve block
Title
Pain measurement during internal rotation
Description
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity
Time Frame
10 minutes after nerve block
Title
Pain measurement at rest
Description
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest
Time Frame
20 minutes after nerve block
Title
Pain measurement during internal rotation
Description
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity
Time Frame
20 minutes after nerve block
Title
pain measurement during positioning for spinal anesthesia
Description
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during changing position from supine to lateral decubitus with flexion of the healthy hip
Time Frame
Just before operation
Title
pain measurement after operation
Description
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable)
Time Frame
6, 12, and 24 hours after operation
Title
the time spending for performing spinal anesthesia
Description
defined as starting of positioning maneuver to removal of spinal needle
Time Frame
Just before operation
Title
quality of position for spinal anesthesia
Description
characterized as unsatisfied, satisfied, good, and excellent by the anesthesiologists performing the spinal anesthesia
Time Frame
Just before operation
Title
the first time of pain perceived by the patient after operation
Description
the time interval between the end of operation and pain first perceived by the patient
Time Frame
Within 48 hours after operation
Title
the time of first request for rescue analgesics after operation
Description
the time interval between the end of operation and the first request for rescue analgesics
Time Frame
Within 48 hours after operation
Title
total consumption of rescue analgesics within 24 hours after the operation
Description
total consumption of rescue analgesics within 24 hours after the operation
Time Frame
Within 24 hours after the operation
Title
the first time of ambulation after operation
Description
the time interval between the end of operation and the first time the patient can ambulate with assistance after operation
Time Frame
Within 72 hours after operation
Title
the time spending for nerve block
Description
defined as from contact of skin by the ultrasound transducer to removal of the needle
Time Frame
Before operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled for surgical treatment for hip fracture American Society of Anesthesiologists (ASA) physical status I-III Exclusion Criteria: allergy to local anesthetics pregnancy inability to understand and use the numerical rating scale (NRS 0-10, 0: no pain, 10: worst pain imaginable) after instruction chronic use of opioids coagulopathy neuropathy severe diabetic mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Chin Kao, MD
Phone
886-975835727
Email
sckao1974@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Chin Kao, MD
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital
City
New Taipei City
ZIP/Postal Code
25160
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Chin Kao, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16983459
Citation
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Results Reference
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Citation
Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.
Results Reference
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PubMed Identifier
29166235
Citation
Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. No abstract available.
Results Reference
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PubMed Identifier
23758305
Citation
Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parenteral opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. Acad Emerg Med. 2013 Jun;20(6):584-91. doi: 10.1111/acem.12154.
Results Reference
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Results Reference
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PubMed Identifier
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Citation
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Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
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Vermeylen K, Desmet M, Leunen I, Soetens F, Neyrinck A, Carens D, Caerts B, Seynaeve P, Hadzic A, Van de Velde M. Supra-inguinal injection for fascia iliaca compartment block results in more consistent spread towards the lumbar plexus than an infra-inguinal injection: a volunteer study. Reg Anesth Pain Med. 2019 Feb 22:rapm-2018-100092. doi: 10.1136/rapm-2018-100092. Online ahead of print.
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Comparing Fascia Iliaca Compartment Block and Pericapsular Nerve Group Block for Hip Fracture Pain Control

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